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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL AGILIS NXT STEERABLE INTRODUCER DUAL-REACH 61 CM SHEATH, SMALL CURL DUAL-REACH; INTRODUCER, CATHETER

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ST. JUDE MEDICAL AGILIS NXT STEERABLE INTRODUCER DUAL-REACH 61 CM SHEATH, SMALL CURL DUAL-REACH; INTRODUCER, CATHETER Back to Search Results
Model Number G408318
Device Problem Gas/Air Leak (2946)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/25/2020
Event Type  malfunction  
Manufacturer Narrative
The results, method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
During an af procedure, an air leak occurred.While inserting the device, air was aspirated into a syringe that connected to the extension part of the sheath.Several aspirations were attempted no air was aspirated.Air was aspirated into the syringe again before re-inserting a ablation catheter into the sheath.No air was aspirated after several aspiration.The procedure was completed with the same sheath with no adverse patient consequences.
 
Manufacturer Narrative
One 8.5f agilis steerable introducer sheath was received for evaluation.The sheath passed pressure and aspiration leak testing with no anomalies observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
 
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Brand Name
AGILIS NXT STEERABLE INTRODUCER DUAL-REACH 61 CM SHEATH, SMALL CURL DUAL-REACH
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
parque industrial, zona franca coyol s.a.
edificio #44b, calle 0, avenida 2, coyol
alajuela, costa rica 1897- 4050
CS  1897-4050
MDR Report Key11032371
MDR Text Key222399347
Report Number3008452825-2020-00696
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05414734206112
UDI-Public05414734206112
Combination Product (y/n)N
PMA/PMN Number
K061363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2023
Device Model NumberG408318
Device Catalogue NumberG408318
Device Lot Number7525931
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/01/2020
Initial Date FDA Received12/17/2020
Supplement Dates Manufacturer Received02/05/2021
Supplement Dates FDA Received02/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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